Welcome to the Dialysafe Study

Title:

Enhancing the Cardiovascular Safety of Hemodialysis Care: a Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions

Précis:

This project is a pragmatic, cluster-randomized comparative effectiveness trial (CRCT) that compares two interventions: (1) Peer Mentoring of patients and (2) healthcare staff training and the use of a checklist to heighten attention to patient clinical factors. The study compares the effectiveness of these two interventions for improving the primary outcome of hemodialysis (HD) session stability, operationalized as intradialytic hypotension (IDH). 

Objectives:

We will compare two interventions to improve the cardiovascular/hemodynamic stability of HD care by pursuing the following specific aims:

●      Aim 1 Conduct a cluster-randomized controlled trial (CRCT) to test and compare the effects of the above HD facility-level interventions on the primary outcome of dialysis session stability over an intervention period of 24 weeks and a post-intervention follow-up period of 12 weeks.

●      Aim 2 Test and compare the effects of the two HD facility-level interventions on secondary patient-centered clinical outcomes, including: patient symptoms, fluid adherence, dialysis adherence, quality of life, hospitalizations and mortality over the same time frame.

●      Aim 3 Identify factors associated with successful implementation of the interventions, and ways in which implementation may influence intervention effectiveness.

In kidney disease, the kidneys don’t work well to remove waste from the blood. Some people with kidney disease have end-stage kidney disease, or kidney failure. These patients have lost their kidney function. People with kidney failure need to have a kidney transplant or dialysis to live. Dialysis is a treatment with a machine that cleans the blood.

Most people in the United States who have kidney failure get dialysis at a clinic three times a week. During dialysis, providers try to keep the sessions stable. This means they try to prevent patients from having complications, such as low blood pressure, known as Intradialytic Hypotension, or IDH. Unstable dialysis sessions can lead to negative outcomes like fatigue, hospital stays, or injury to the heart and other organs. Unstable sessions are common in the United States.   

The research team is working with 20 dialysis clinics across the United States. The team is assigning each clinic to one of four groups by chance.

In the first group, clinics receive only the training for healthcare providers. Staff at these clinics learn how to prevent unstable dialysis sessions. Staff also have a checklist to help them identify patients who are more likely to have an unstable session.

Patients at clinics in the second group take part in a patient education program. The program includes peer mentoring from trained patients who have dialysis experience. Peer mentors have five meetings with patients using a tablet computer. At these meetings, peer mentors help patients change their behavior to help them have more stable sessions. Patients at clinics in this group also complete interactive online modules on a tablet to reinforce discussions with peer mentors.

Clinics in the third group receive provider training and also offer the patient education program. In the fourth group, clinics offer usual care, without either the provider training or the patient education program.

Patients are at the center of Dialysafe study, which hopes to improve patient outcomes, including:

• Patient recovery time after dialysis

• Patient symptoms reported at each dialysis session

• Weight gain between dialysis sessions

• Number of minutes of dialysis time, and number of sessions, missed per week

• Patient quality of life

• Whether the patient was hospitalized for any reason

• Whether the patient died of any cause

Patients are also involved in each stage of the study. Patients are included on the study team and Advisory Committee, and several have been surveyed in order to make the study and interventions as patient-friendly as possible. As peer mentors, patients are also at the heart of delivering Patient Education Intervention.  

The Dialysafe Study is made possible by partnerships between University of Michigan, Fresenius Medical Care North America, the National Kidney Foundation, the University of California at Irvine, and the 5-Diamond Patient Safety Program. Dialysafe is funded by the Patient-Centered Outcomes Research Institute (PCORI).